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Dutoprol

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Dutoprol

INDICATIONS

Hypertension

DUTOPROL is a combination tablet of metoprolol succinate, a beta adrenoceptor blocking agent and hydrochlorothiazide, a diuretic. DUTOPROL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including metoprolol and hydrochlorothiazide.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (eg, on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

DUTOPROL may be administered with other antihypertensive agents.

DOSAGE AND ADMINISTRATION

Dosing must be individualized considering baseline and target blood pressure as well as experience with individual agents.

The side effects (see WARNINGS) of metoprolol succinate extended release are a mixture of dose-dependent phenomena (primarily bradycardia and fatigue); those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of metoprolol succinate extended release and hydrochlorothiazide will be associated with both sets of dose independent side effects. To minimize the known dose-related tolerability and safety-related effects of the individual agents, consideration should be given to initiating treatment at less than their maximum doses.

DUTOPROL may be administered with other antihypertensive agents.

DUTOPROL may be administered with or without food.

DUTOPROL is administered once daily.

Hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg once daily.

Patients usually do not require doses in excess of 50 mg hydrochlorothiazide daily when used concomitantly with other antihypertensive agents.

The usual initial dose of metoprolol succinate extended release is 25 to 100 mg daily in a single dose.

Metoprolol succinate extended release doses greater than 400 mg have not been studied.

Replacement Therapy

DUTOPROL may be substituted for treatment with individual components.

Dose Titration by Clinical Effect

Use the dose necessary based on patient response once the need for combination product is established. Response rates are greater at higher doses.

Patients with insufficient blood pressure effects with metoprolol succinate extended release or hydrochlorothiazide alone may be switched to DUTOPROL.

The lowest DUTOPROL tablet available is 25/12.5 mg. A 50/6.25 mg dose can be achieved by splitting the 100/12.5 mg tablet. Subsequently titration may be carried out every 2 weeks up to a maximum of 200/25 mg (two DUTOPROL 100/12.5 mg tablets).

Patients with Renal Impairment

The usual regimens of therapy with DUTOPROL may be followed as long as the patient's creatinine clearance is > 30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so DUTOPROL is not recommended.

Patients with Hepatic Impairment

The usual regimens of therapy with DUTOPROL may be followed in patients with mild hepatic impairment. In patients with moderate hepatic impairment, consideration should be given to initiation of DUTOPROL with lower doses of hydrochlorothiazide.

HOW SUPPLIED

DUTOPROL 25/12.5 (NDC 0310-1087-05)

Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IH” on one side, are supplied in bottles of 100.

DUTOPROL 50/12.5 (NDC 0310-1095-05)

Light orange, circular, biconvex, film-coated tablet engraved with “A” above “IK” on one side, are supplied in bottles of 100.

DUTOPROL 100/12.5 (NDC 0310-1097-05)

Yellow, circular, biconvex, film-coated tablet engraved with “A” above “IL” on one side and scored on the other side, are supplied in bottles of 100.

Store at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). (See USP Controlled Room Temperature.)

Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. By: AstraZeneca AB S-151 85 Södertälje, Sweden. Rev. 11/2011

Last reviewed on RxList: 1/9/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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